Lumbar Spinal StenosisNCT04795284
Biomechanical Parameters of Gait in Patients with Symptomatic Lumbar Spinal Stenosis and Healthy Elderly.
An observational study of Lumbar Spinal Stenosis and Healthy Elderly, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial summary
The aim of this study is to compare biomechanical walking parameters between patients with symptomatic lumbar spinal stenosis and healthy elderly. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Healthy Elderly
- How many people
- 135 participants
- Where
- 1 siteCanada
- Study dates
- 9 Sep 2020to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group 1: Patients with a symptomatic lumbar spinal stenosis Group 2: Healthy elderly from the community
Who may be able to join
- Patients with lumbar spinal stenosis
- Having a diagnosis of lumbar spinal stenosis (at least 1 level)
- Having neurologic claudication due to the lumbar spinal stenosis
- Healthy elderly
- Being over 50 years old of age
- No back or leg pain during walking
Who cannot join
- Symptomatic hip or knee Ostearthritis
- Not able to give their free consent
- Being in a wheelchair (not able to walk 30 meters)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G9A 5H7
About this study
The aim of this study is to compare biomechanical walking parameters between patients with symptomatic lumbar spinal stenosis and healthy elderly.
- Conditions
- Lumbar Spinal Stenosis, Healthy Elderly
- Keywords
- Lumbar Spinal Stenosis, Healthy elderly, Walking capacity, Biomechanical parameters
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with symptomatic lumbar spinal stenosis | 30-meter walking task (15 meters round trip) following by a rest period of 2 minutes. Participants are invited to perform the 30-meter walking task twice. Inertial sensors are put on each participant foot. | |
| Healthy elderly | 30-meter walking task (15 meters round trip) following by a rest period of 2 minutes. Participants are invited to perform the 30-meter walking task twice. Inertial sensors are put on each participant foot. |
What is being measured
The primary outcome is the main question the study is designed to answer.
biomechanical walking parameters (gait cycle, stride length, walking time, walking speed, swing width, minimal toe clearance)
Gait cycle = % stance phase, % swing phase / Stride length = describes the distance between two successive footprints on the ground / walking time = time to complete the 30-meters walking test in seconds / walking speed = walking stride velocity measured in meter/second / swing width = the maximal lateral excursion of the foot during the swing phase / minimal toe clearance = minimum height of the toes during the swing phase (in meter)
Measured: During the 30-meter walking test
Quality of life (Euro-Qol - 5D)
Quality of life related to mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Each category has a score ranging from 1 to 3 and higher values indicate a worst outcome.
Measured: One time (before the completion of the 30-meter walking test)
International Physical Activity Questionnaire (IPAQ)
Physical activity habits. IPAQ score range from 1 to 3 where a score of 3 indicates a higher practice of physical activity
Measured: One time (before the completion of the 30-meter walking test)
Secondary outcomes (1)
French-Canadian adaptation of Swiss Spinal Stenosis Questionnaires (FC-SSSQ)
Pain, function and satisfaction related to lumbar spinal stenosis. Pain subscale score range from 7 to 35 with higher values indicate a worst outcome, Function subscale score range from 5 to 20 with higher values indicate a worst outcome, Satisfaction subscale score range from 6 to 24 with higher values indicate a worst outcome. The total score is composed of the three subscales and range from 18 to 79.
Measured: One time (before the completion of the 30-meter walking test) - Only for patients with lumbar spinal stenosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start9 Sep 2020
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Descarreaux, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795284
- Sponsor's protocol ID
- UQTR_gaitup_2020
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2021
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Parameters of Gait in Patients with Symptomatic Lumbar Spinal Stenosis and Healthy Elderly.
- ClinicalTrials.gov ID
- NCT04795284
- Acronym / sponsor ID
- UQTR_gaitup_2020
- Conditions
- Lumbar Spinal Stenosis, Healthy Elderly
- Keywords
- Lumbar Spinal Stenosis, Healthy elderly, Walking capacity, Biomechanical parameters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare biomechanical walking parameters between patients with symptomatic lumbar spinal stenosis and healthy elderly.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with symptomatic lumbar spinal stenosis | – | –30-meter walking task (15 meters round trip) following by a rest period of 2 minutes. Participants are invited to perform the 30-meter walking task twice. Inertial sensors are put on each participant foot. |
| Healthy elderly | – | –30-meter walking task (15 meters round trip) following by a rest period of 2 minutes. Participants are invited to perform the 30-meter walking task twice. Inertial sensors are put on each participant foot. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: Patients with a symptomatic lumbar spinal stenosis Group 2: Healthy elderly from the community
Key inclusion criteria (6 listed)
- Patients with lumbar spinal stenosis
- Having a diagnosis of lumbar spinal stenosis (at least 1 level)
- Having neurologic claudication due to the lumbar spinal stenosis
- Healthy elderly
- Being over 50 years old of age
Key exclusion criteria (3 listed)
- Symptomatic hip or knee Ostearthritis
- Not able to give their free consent
- Being in a wheelchair (not able to walk 30 meters)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
biomechanical walking parameters (gait cycle, stride length, walking time, walking speed, swing width, minimal toe clearance)
Time frame: During the 30-meter walking test
Gait cycle = % stance phase, % swing phase / Stride length = describes the distance between two successive footprints on the ground / walking time = time to complete the 30-meters walking test in seconds / walking speed = walking stride velocity measured in meter/second / swing width = the maximal lateral excursion of the foot during the swing phase / minimal toe clearance = minimum height of the toes during the swing phase (in meter)
Quality of life (Euro-Qol - 5D)
Time frame: One time (before the completion of the 30-meter walking test)
Quality of life related to mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Each category has a score ranging from 1 to 3 and higher values indicate a worst outcome.
International Physical Activity Questionnaire (IPAQ)
Time frame: One time (before the completion of the 30-meter walking test)
Physical activity habits. IPAQ score range from 1 to 3 where a score of 3 indicates a higher practice of physical activity
1 secondary outcome
French-Canadian adaptation of Swiss Spinal Stenosis Questionnaires (FC-SSSQ)
Time frame: One time (before the completion of the 30-meter walking test) - Only for patients with lumbar spinal stenosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis and Healthy Elderly, run by Université du Québec à Trois-Rivières at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biomechanical walking parameters (gait cycle, stride length, walking time, walking speed, swing width, minimal toe clearance) (time frame: During the 30-meter walking test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.